Director, Clinical Development

POSITION SUMMARY

The Director/Senior Director, Clinical Development will be responsible for all clinical trial related activities for Brelovitug, a key asset in Phase 3 on a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to protocol development, support study startup, oversight of trial execution, recruitment, ongoing clinical development management and closeout as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis are required. Participation in health authority meetings and regulatory filing activities are also part of this role. The Director/Senior Director, Clinical Development operates in collaboration with other functions including internal Safety, Regulatory, Biometrics, and Clinical Operations teams.

JOB FUNCTIONS/RESPONSIBILITIES

Leadership and management of all aspects of complex, global development clinical studies.

Primary point of contact for clinical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate

Integration of clinical/regulatory strategy into global product development strategy

Primary liaison for internal Clinical Operations for site selection, site start-up activities, study management and closeout activities, etc.

Support the creation of and/or review of clinical slides for internal and external meetings (e.g. Investigator Meetings, SIVs, IDMCs, Advisory Boards, etc.)

Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, Development Safety Update Reports etc.

Strategic input on the overall development plan, internal and external evaluation of new studies

Oversight of clinical aspects of compliance of and inspection readiness in completed, ongoing and starting clinical trials

Collaboration in the analysis and writing of scientific publications/presentations

Works closely with cross-functional team members

Co-leads Study Management Team with Clinical Operations lead.

QUALIFICATIONS

Education/Experience: MD, PharmD, PhD or equivalent is preferred with 3 years of drug development in industry, academia, or a related environment, working within cross-functional project or program teams with proven success.

Experience in Liver or rare disease a plus.

Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.

Knowledge, Skills and Abilities:

• Demonstrated accountability for delivery on clinical studies
• Leadership in clinical development programs and multidisciplinary trial teams
• Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance
• Ability to understand and communicate risks, as well as develop and execute contingency plans
• Ability to think creatively and develop and execute in a fast-paced environment
• Detail oriented with exceptional organizational skills
• Effective communicator with strong verbal and written skills
• Ability to identify issues, analyze situations and provide effective solutions
• Solid understanding of the clinical development process
• Knowledge of applicable regulatory

Work Environment:

This is a high growth, fast-paced organization. The ability to be productive and successful in a work environment is critical.

Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 20% of work time.

The salary range for this position is $220,000 to $240,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.